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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

CE mark

Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance

MedDevice Startups Staff · 4 days ago · 2 min read · Via MassDevice

Globus Medical said on September 4 that its Excelsius3D imaging system now carries a CE mark for spine and cranial surgery in the European Union and the United Kingdom. The same system cleared the FDA about five years ago.

Excelsius3D puts three modes in one mobile unit: 3D cone beam CT, 2D fluoroscopy and digital radiography. It moves on omnidirectional wheels and is meant to run alongside the company's ExcelsiusGPS navigation and robotics line. Globus is based in Audubon, Pennsylvania.

The five year gap is the part worth reading if you are planning a European launch. A US clearance buys you nothing under MDR, and a notified body queue can outlast the product generation you filed with. Budget the EU submission as its own program, not as a translation of the 510(k).

Questions & Answers

What is the Globus Medical Excelsius3D imaging system?

Excelsius3D is a mobile imaging system from Globus Medical that combines 3D cone beam CT, 2D fluoroscopy and digital radiography in one unit. It is built to work alongside the company's ExcelsiusGPS navigation and robotics platform.

What does the Globus Medical Excelsius3D CE mark cover?

The CE mark Globus Medical announced on September 4, 2026 covers spine and cranial surgical procedures in the European Union and the United Kingdom.

When was Excelsius3D cleared by the FDA?

Globus Medical received FDA clearance for Excelsius3D in the United States about five years before the September 2026 CE mark.

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